Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia

NCT ID: NCT00554047

Last Updated: 2011-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC) currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs are increasingly involved in post-diagnosis treatment and coordination of care, which probably is very important for patients and caregivers, but also very time consuming and expensive. This study will focus on the important question whether this complex post-diagnosis treatment and care coordination, evaluated both on effectiveness and costs, should be carried out by MMCs (intervention) or by General Practitioners (GPs) (control) as pivot of delivery of health care for these patients.

Objectives: To determine MMCs' effectiveness and cost-effectiveness in post-diagnosis treatment and care-coordination for dementia-patients and their caregivers compared to the post-diagnosis treatment and care coordination by GPs.

Time schedule: 12 months for including patients and their caregivers and 12 months of follow-up.

Annex Study: Specifically for the Health Technology Assessment (HTA) methodology study the main study will be extended with some experimental proxy measurements and alternative measurement approaches.

The objective of this Annex-study is to explore the feasibility and validity of Health Related Quality of Life (HRQL) value measurement in dementia patients. And to study the characteristics of proxy rating in HRQL research in dementia and the suitability and validity of yielding HRQL measurements by proxy assessment. Furthermore to explore the validity, reliability, and feasibility of the EQ5D and EQ6D in dementia research (in patients and in/by proxies); response shift, and alternative (more simple) methods of HRQL measurement and validate the Dutch versions of the QOL-AD and the use of the CarerQol-7D in dementia research.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Multidisciplinary Memory Clinic

Group Type EXPERIMENTAL

Multidisciplinary Memory Clinic

Intervention Type OTHER

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)

2

General practitioner

Group Type ACTIVE_COMPARATOR

General Practitioners

Intervention Type OTHER

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multidisciplinary Memory Clinic

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)

Intervention Type OTHER

General Practitioners

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* A patient with a new dementia diagnosis made at the MMC of the participating centre fulfilling DSM-IV-TR criteria with a CDR 0.5, 1 or 2
* Each patient has a caregiver
* Both patients and caregivers can provide informed consent for participation in the study

Exclusion Criteria

* Life expectancy less than 1 year
* Living in a nursing home
* Already evaluated as being suitable for living in a nursing home
* Data collection impossible (e.g., due to severe visual/hearing/language impairment, mood disorder, or behavioral disturbances)
* The patient's general practitioner does not agree to participate
* Already participating in another study
* The patient visits the MMC for a second opinion
* Travel distance between MMC and patient's living address more than 50 kilometers
* A definite indication for memory clinic follow up:

* A definite need for symptomatic drug treatment as judged by treating physician (e.g., Dementia with Lewy Bodies)
* A definite need for specialist guidance as judged by treating physician (e.g., Creutzfeldt-Jakob Disease, severe Frontotemporal Lobar Disease)
* A definite wish for symptomatic drug treatment by patient or caregiver
* A definite need for guidance from psychiatric services involved in the memory clinic
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Netherlands Alzheimer Foundation

OTHER

Sponsor Role collaborator

Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Stockholm Health Economics AB

UNKNOWN

Sponsor Role collaborator

Slingeland Hospital

OTHER

Sponsor Role collaborator

Elkerliek Hospital

OTHER

Sponsor Role collaborator

Ggz Oost Brabant

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Prof. Dr. M. Olde Rikkert, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre St Radboud, Nijmegen

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VU Medical Center, Alzheimer Centre

Amsterdam, , Netherlands

Site Status

Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics

Arnhem, , Netherlands

Site Status

GGZ Oost Brabant, Department of Geriatrics

Boxmeer, , Netherlands

Site Status

Slingeland Hospital, Department of Geriatrics

Doetinchem, , Netherlands

Site Status

Hospital Gelderse Vallei, Department of Geriatrics

Ede, , Netherlands

Site Status

Catharina hospital, Department of Geriatrics

Eindhoven, , Netherlands

Site Status

Elkerliek Hospital, Department of Geriatrics

Helmond, , Netherlands

Site Status

University Hospital Maastricht, Alzheimer Centre

Maastricht, , Netherlands

Site Status

University Medical Centre St Radboud, Alzheimer Centre

Nijmegen, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

Meeuwsen E, Melis R, van der Aa G, Goluke-Willemse G, de Leest B, van Raak F, Scholzel-Dorenbos C, Verheijen D, Verhey F, Visser M, Wolfs C, Adang E, Olde Rikkert M. Cost-effectiveness of one year dementia follow-up care by memory clinics or general practitioners: economic evaluation of a randomised controlled trial. PLoS One. 2013 Nov 25;8(11):e79797. doi: 10.1371/journal.pone.0079797. eCollection 2013.

Reference Type DERIVED
PMID: 24282511 (View on PubMed)

Meeuwsen EJ, Melis RJ, Van Der Aa GC, Goluke-Willemse GA, De Leest BJ, Van Raak FH, Scholzel-Dorenbos CJ, Verheijen DC, Verhey FR, Visser MC, Wolfs CA, Adang EM, Olde Rikkert MG. Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial. BMJ. 2012 May 15;344:e3086. doi: 10.1136/bmj.e3086.

Reference Type DERIVED
PMID: 22589500 (View on PubMed)

Meeuwsen EJ, German P, Melis RJ, Adang EM, Goluke-Willemse GA, Krabbe PF, de Leest BJ, van Raak FH, Scholzel-Dorenbos CJ, Visser MC, Wolfs CA, Vliek S, Rikkert MG. Cost-effectiveness of post-diagnosis treatment in dementia coordinated by Multidisciplinary Memory Clinics in comparison to treatment coordinated by general practitioners: an example of a pragmatic trial. J Nutr Health Aging. 2009 Mar;13(3):242-8. doi: 10.1007/s12603-009-0066-1.

Reference Type DERIVED
PMID: 19262961 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZonMw 80-007022-98-07703

Identifier Type: -

Identifier Source: secondary_id

ZonMw 945-07-7039

Identifier Type: -

Identifier Source: secondary_id

ADE 072510

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Maximizing Independence at Home (MIND at Home)
NCT01283750 COMPLETED PHASE2/PHASE3